Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled clinical trial aims to evaluate the antibacterial efficacy and stability of strontium-incorporated hydroxyapatite (Sr-HA) coated orthodontic mini-screws (OMSs) used for maxillary canine retraction. A double-blind, split-mouth design was employed, involving 20 patients (aged 16-20 years), each receiving two titanium alloy mini-screws (1.6 mm × 8 mm): one coated with Sr-HA (5% concentration via electrochemical deposition) and one uncoated control. A total of 40 mini-screws were assessed. Following upper first premolar extractions, canine retraction was initiated using 150 g NiTi coil springs on 17×25 SS archwires. Mini-screws were placed between the upper second premolar and first molar without flap elevation or pilot hole drilling. Parameters including screw stability, antimicrobial activity, and gingival blood flow were monitored over a 4-month period. The incorporation of Sr-HA is hypothesized to enhance mini-screw osseointegration, reduce peri-implant inflammation, and improve clinical outcomes by leveraging the osteogenic and antibacterial properties of strontium. This study aims to provide evidence supporting the use of Sr-HA coatings to reduce mini-screw failure rates in orthodontic treatment.
Aim of the study:
The aim of this study is to evaluate the antibacterial efficacy and stability of strontium- incorporated hydroxyapatite (Sr-HA) coated orthodontic mini- screws used in maxillary canine retraction in comparison to uncoated mini- screws.
Material and methods:
Outcome Measurement:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : uncoated OMSs. | No Intervention | Mini- screw uncoated by Sr-HA | |
| Group 2: coated OMSs by Sr-HA | Experimental | Mini-screw coated by Sr-HA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company | Other | Maxillary canine retraction by mini-screw loaded with 150g Niti coil spring |
| Measure | Description | Time Frame |
|---|---|---|
| Orthodontic mini-screws stability | Mean value of orthodontic mini-screw stability assessed using the Periotest device Measurement Tool: A Periotest device (manufactured by Medizintechnik Gulden, Germany) will be used to evaluate the mechanical stability of the orthodontic mini-screws. Unit of Measure: Periotest Values (PTV), expressed as numerical values ranging from -8 (high stability) to +50 (low stability). Assessment Method: The stability of both coated (Strontium-incorporated Hydroxyapatite) and uncoated orthodontic mini-screws will be measured and compared at specific time intervals throughout the study period. | Four mounth |
| Measure | Description | Time Frame |
|---|---|---|
| Anti microbial effect | Mean concentration of bacterial adhesion on orthodontic mini-screw surfaces assessed by Enzyme-Linked Immunosorbent Assay Measurement Tool: Enzyme-Linked Immunosorbent Assay (ELISA) will be employed to quantify the level of bacterial colonization on the surface of the mini-screws. Unit of Measure: Colony Forming Units per milliliter (CFU/mL), or Optical Density (OD) values at a specific wavelength (typically 600 nm), depending on the ELISA protocol used. Assessment Method: The antimicrobial effect of the Strontium-incorporated Hydroxyapatite coating will be evaluated by comparing the level of bacterial adhesion on coated versus uncoated mini-screw surfaces. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hind H jasim Al-khazrajy, Bachelors | Contact | 01555178219 | hindhhjk@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
individual participants available upon request
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2025 | Aug 10, 2025 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Four mounth |
| D009057 |
| Stomatognathic Diseases |